Photo of Katia Merten-Lentz

Where does laboratory produced meat fit in the regulatory frameworks of the US and the European Union?

Meat produced in a laboratory is close to coming to market, raising questions about the regulatory hurdles the US and EU may put in place

Published 11 Dec 2018 at EU Food Law

ANALYSIS

On 16th November 2018, the US Department of Agriculture and the US Food and Drug Administration announced that they had reached an agreement on a joint regulatory framework on laboratory made, cultured meat, also called in vitro meat. The Agencies have not yet revealed which framework will apply to this new way of making meat, but their respective roles have been clarified, as Katia Merten-Lentz of international law firm, Keller & Heckman, reports.

Cultured meat, or in vitro meat, is a form of cellular agriculture allowing the growth of meat from animal cells. Over the last few years, the price of producing this meat has dropped drastically, raising the possibility of these meats hitting the market.

However, these developments have also raised questions about their regulatory status, safety and labelling issues.

The statement released by the USDA and the FDA in November is another step towards the setting up of a regulatory framework regarding in vitro meat. The agencies have decided to oversee jointly the production of in vitro meat , according to their regular competencies: the FDA will oversee the first stages regarding cell-culture technology, and USDA the production and labelling of in vitro-meat. The joint statement of USDA and FDA does not explain which regulatory status will be applied to lab meat. But this status – as well as labelling issues – will have to be settled before the meat is placed on the market.

 

Regulatory status and safety assessment of meat in vitro

The US and EU regulatory framework regarding meat in vitro will differ.Regarding the US, several hypotheses can be explored. The first important hurdle is that it is arguably difficult to consider that in vitro meat fits in the definition of “meat product” as defined in the Federal Meat Inspection Act (FMIA), since FMIA assumes a meat food product is derived from a carcass.

If FMIA is inapplicable to culture meat, the rules regarding conventional foods would probably apply, and the FDA’s Biotechnology Policy could provide some help  in analysing the status of cultured meat.

It is also possible that in vitro meat could be considered to be a food additive.

The current method for growing in vitro meat consists of using a cell culture medium or scaffold, which is a structure where the cells attach to in order to allow growth, and cellular growth factors.

As explained by the Food and Drug Law Institute , the FDA may consider that these substances are food additives, since they are intentionally added to a food.

If it is the case, they will have to be authorised, unless they meet the two so called GRAS criteria (generally recognized as safe) i.e.: there is a reasonable certainty of no harm; and the intended use of the substance in food must be recognised as safe by qualified experts based on publicly available scientific information (general recognition standard).

Moreover, the safety of the primary cells used would also have to be asserted, since they are genetically modified cell lines. This may pose a hurdle, as, according to the US Consumers Union, “these lines exhibit the characteristics of a cancerous cell”.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

Indeed, in vitro meat falls under a relevant category in the Novel Foods Regulation that explicitly refers to food produced from cell culture or tissue culture derived from animals.

In its answer to a parliamentary question on this topic in October, the European Commission confirmed that in vitro meat may fall in this category and must then be considered as a novel food.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

For being authorised as a novel food, the producers of in vitro meat will have to file an application which must include all relevant data.If the product is deemed safe after a scientific assessment by the European Food Safety Authority (EFSA), the Commission can enact a Regulation to authorise in vitro meat.  The Commission recently confirmed that no application for the authorisation of in vitro meat has been received so far.

Therefore, in vitro meat cannot yet be placed on the market, and any such meat would be seized by the authorities.

This is what happened in December 2017, when tasting experiments of cultured meat made by the company JUST were organized in the Netherlands, and the Dutch Safety Authority sealed the products to prevent them from being consumed.

Issues regarding labelling

The Novel Foods Regulation states that when novel foods are added to the Union list of authorized novel food, there can be requirements regarding labelling, in order to fully inform the consumer, for instance by describing the food or its composition. It is more than likely that specifications will be added for in vitro meat.

In any case the EU Regulation on Food Information to Consumers (also known as ‘the FIC Regulation’) will apply to in vitro meat once it is authorised, but its application may prove challenging.

For instance, there is an obligation to indicate on the label the denomination of a food, but there are unsolved issues regarding the denomination of in vitro meat.

Since this food is not on the market yet, there is no legal name and no customary name either. Many names already coexist (in vitro meat, cultured meat, clean meat, lab meat, etc.), and the choice of the name is quite touchy.

Since the FIC Regulation’s main objective is to ensure that fair, clear and precise information is provided to the consumers – for instance about the manufacturing or production method – it seems very likely that operators will have to ensure that the product name makes clear that the meat has been grown in a lab.

Moreover, in vitro meat does not comply with the current European definition of “meat”. According to the FIC Regulation, the definition of meat – for labelling purpose – is: ‘skeletal muscles of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissue (…)’.  In vitro meat neither consists of “skeletal muscles” (‘muscles under the voluntary control of the somatic nervous system’) nor of ‘naturally’ included or adherent tissues, so it would mean that the term ‘meat’ could not be used in the current state of the EU legislation.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

The exact same issue applies for the US as in vitro meat does not comply exactly with the definition of “meat food product” under FMIA. In the EU, there are also specific issues regarding the labelling of meat that will be difficult to apply to in vitro meat.

Several regulations make the indication of the country of origin or place of provenance of meat mandatory.  However, for in vitro meat, since there is no animal being born, reared or slaughtered, it will be virtually impossible to apply this disposition.

In the US, the public is given the opportunity to comment on the regulatory issues regarding lab meat until 26 December 2018. The expected statements that will follow from the public agencies will hopefully reveal for operators the first outlines for a regulatory framework for in vitro meat.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

Photo of Katia Merten-Lentz

Published 28 November 2018 at EG Policy and powered by EU Food Law.

 

In April 2018, the European Commission officially proposed a targeted revision of the General Food Law Regulation (EC 178/2002) to improve the transparency of scientific studies in the food safety area, writes Katia Merten-Lentz of international food law firm Keller & Heckman.

This proposal follows a European Citizens’ Initiative submitted in October 2017 focusing on pesticides and food safety.

However, the main principles of food safety in the EU, i.e. responsibility of the operator and traceability, will not be part of this revision.

The Commission recently explained in its answer to a parliamentary question that the current framework had resulted, globally, in positive outcomes and did not have to be amended for now.

 

Keeping the preventative approach

European food safety regulation is primarily based on a preventive approach, in which food business operators (FBOs) hold the primary legal responsibility for ensuring compliance with food law.

The legal framework results from two main instruments combined:

  • the General Food Law Regulation (GFL), which lays down the general principle that all operators in the supply chain may only place safe foods on the market; and
  • the EU Regulation (No 852/2004) on the hygiene of foodstuffs.

The EU Regulation on hygiene states that FBOs must implement a food safety management system, which prevents and reduces food-borne hazards, and which is based on the hazard analysis and critical control point (HACCP) principles.

These flexible principles are developed to enable operators to identify points during the production where potential hazards may occur (related to harmful microorganisms, chemical hazards, packaging or equipment quality, etc), analyse the probability of those hazards happening, and set up controls and corrective actions to tackle them, such as sampling the food to check microbiological criteria for instance.

The Regulation on hygiene also provides a set of rules on good hygiene practice, covering aspects like cleaning and disinfection, pest control, waste management, hygiene of the staff and transport.

Operators must also ensure that products comply with specific EU provisions on safety, such as the regulations setting up maximum levels for certain contaminants and residue levels of pesticides in food, beyond which a food may not be placed on the market.

If, despite the preventive measures, an unsafe product is placed on the market, the GFL Regulation provides for additional dispositions to protect the safety of consumers.

The GFL imposes general obligations on food business operators in terms of traceability, notification of food safety incidents and withdrawal and recall of unsafe food.

The obligation of ‘traceability’ means that the operator must be able to identify both their suppliers and customers through all stages of production, processing and distribution. Traceability is essential to facilitate withdrawal and recall of food.

Indeed, if an operator believes that a food that it has imported, manufactured or distributed is not in compliance with food safety requirements, he or she must withdraw it immediately, by removing it from the supply chain. If this product might have been already bought by consumers, it has to be recalled in addition. The FBO also has to notify the national authorities of the withdrawal as soon as possible.

When a serious health hazard is detected, the national authorities inform the European Commission and the other Member States via a platform called the Rapid Alert System for Food and Feed.  If deemed necessary, the Commission can adopt emergency measures – such as suspending the placing on the market of products – to mitigate the risks.

 

Reform on transparency of the risk assessments for food-related authorisations

After completing, in January 2018, the REFIT on the GFL Regulation, the Commission concluded that the core principles regarding risk analysis, primary responsibilities of FBO and traceability, have been successful in protecting public health.

However, the Commission noted a lack of trust from the citizens regarding transparency of risk analysis, particularly with regard to the authorisation dossiers.

While on the one hand the operators are responsible for the safety of the products they put on the market, on the other hand, the European Food Safety Authority (EFSA) plays a major part by assessing the dossiers submitted by operators seeking authorisation for novel foods, additives, plant protection products and food improvement agents.

The GFL Regulation lays down that EFSA’s assessment is primarily based on industry studies – therefore generated by the applicant. Moreover, EFSA is bound by strict confidentiality rules with regards to these studies. These elements have a negative impact on consumers’ trust. To tackle this issue, the Commission has made several proposals to ensure more transparency during the risk assessment process.

The reform proposes free access for citizens to all safety related information submitted by the industry, and the creation of an European Register of studies.

The proposal also includes consultation of stakeholders and public on studies submitted by the industry, as well as an increase in the EU member states’ involvement in EFSA. Finally, the Commission also wants to strengthen risk communication to citizens by promoting public awareness and better explaining scientific opinions.

The proposal is currently being examined by the European Parliament in first reading, and the main sticking point in the discussions relates to the level of confidentiality that must be granted to industry studies.

The first trilogues are expected late December and early January, which means that the reform will probably be adopted during the course of 2019, but certainly not under the current Parliament.